BELOW ZERO TOLERANCE

It’s difficult to imagine a world where we can’t take for granted that our goods will arrive on time and in perfect condition. In particular, those products that need to be kept at a certain temperature to maintain their quality. No wonder, as transporting temperature-sensitive goods is something that started back in 1797, when British fisherman used ice to preserve their fish stockpiles before selling them onto their customers. Since then, thankfully, a lot has changed and today’s cold chain is a sophisticated, technology-driven logistics eco-system that instils confidence in customers. We now have the ability to not only deliver food in pristine condition, but, more importantly, pharmaceutical drugs reach patients in need, safely. This infrastructure is vital to the modern world, which is highlighted by the prediction that investment in biopharma cold chain logistics will reach over $18 billion by 2022.

Though this steady progress is something to be proud of, 2020 saw the entire supply chain, in particular the cold chain, being put to the test. The pandemic led to challenges on an unprecedented scale, from ports being closed to commercial flights being grounded but while this wasn’t something we could have anticipated, the industry managed to rapidly adapt. 

Within the pharmaceutical industry, drug portfolios are evolving towards more structurally complex biotechnology drugs, which puts more pressure on the supply chain. Though vaccines are one important part of this, they are not the only high priority item that relies heavily on cold chain logistics.

Gene therapy, which is the removal or change in the content of a patient’s genetic code with the goal of treating or curing a disease, is an intricate and delicate process. Uncountable hours of scientific research are needed to develop these genes and to identify the best means of delivery, as the finished products require stringent temperature controls and are viable only for a short space of time.

For example, with autologous therapies, where cells from transplants come from the person receiving the transplant, biological material must be collected directly from the patient and transferred to the manufacturing site. The modified, personalized therapy is then shipped back to be administered to the patient.

The complexity of managing this process is immense. These patients could be based anywhere in the world, which means a challenging collection process may be required. Both the patient cells and therapy must also be shipped using liquid nitrogen or under refrigerated conditions and typically must arrive within 40–50 hours. Strict temperature monitoring is critical throughout and careful understanding of regulations is also required. A single error at any point can have costly implications for both the clinical trial sponsors and the patients involved.

With the huge amount of work and vast amounts of money that is invested into harvesting and synthesizing these cells, the same effort must be reciprocated in how they are stored, kept safe and ready to move to the patient.

The same is true when it comes to the other side of the gene therapy coin, allogenic gene therapy, where large batches of drugs are developed from unrelated donor tissues and used to treat hundreds or thousands of patients.

Unlike autologous therapies — where the patient and their location are known from the outset — allogeneic therapies may need to be distributed to patients across a wide geographic area. This means that careful attention must be paid when it comes to understanding the storage and distribution environment necessary to deliver the treatment to the patient. This is vital to ensuring that safety and efficacy is never compromised during its journey.

The challenge of this diversely located patient base should not be underestimated. Different modes of transport may be needed (land and air) and there may be environmental and weather hazards that require the careful integration of suitable packaging, labelling and temperature monitoring for every stage of the shipment. Added to all of this, logistics must also align with the overall patient journey, to ensure treatments are shipped to locations that are as convenient for the end-users as possible.

From rigorous quality assurance protocols to crisis planning and investment in smart technologies, shipping high priority items is not an easy task but it’s critical, impacting the fate of millions of patients.